Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000788
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the pharmacokinetics and safety of concomitant administration of methadone and fluconazole
Injection drug users constitute the second largest subset of the US population at risk for HIV infection and AIDS-associated mortality Narcotic addiction is often treated by use of methadone Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis but it is unknown whether fluconazole affects methadone metabolism which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination
Injection drug users constitute the second largest subset of the US population at risk for HIV infection and AIDS-associated mortality Narcotic addiction is often treated by use of methadone Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis but it is unknown whether fluconazole affects methadone metabolism which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination
Detailed Description:
Injection drug users constitute the second largest subset of the US population at risk for HIV infection and AIDS-associated mortality Narcotic addiction is often treated by use of methadone Fluconazole has been shown to be highly effective in treating symptomatic mucosal candidiasis but it is unknown whether fluconazole affects methadone metabolism which could result in symptoms of methadone withdrawal or overdose in patients taking the drugs in combination
Patients are randomized to receive methadone plus either fluconazole or placebo in clinic daily for 16 days Study drugs are administered as close to 8 AM as possible Patients must visit the Fort Greene clinic on study days 1 2 15 and 16 they may receive treatment at their home clinics on days 3 through 14
Patients are randomized to receive methadone plus either fluconazole or placebo in clinic daily for 16 days Study drugs are administered as close to 8 AM as possible Patients must visit the Fort Greene clinic on study days 1 2 15 and 16 they may receive treatment at their home clinics on days 3 through 14
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11580 | REGISTRY | DAIDS ES Registry Number | None |